PRIMO MEDICAL GROUP

Primo Medical Group specializes in cardiac transseptal access sets, with a focus on steerable introducers. These devices are specifically designed for interventional cardiac procedures, enabling precise catheter navigation across the atrial septum. This functionality supports critical treatments like ablation and the closure of septal defects, where accurate access and control are essential.

Primo Medical Group is headquartered in the United States. The company’s devices are regulated in the U.S., where they fall under the jurisdiction of the FDA. The regulatory framework ensures that these products meet the necessary safety and performance standards for their intended use in cardiac interventions.

Primo Medical Group’s devices are classified as Class II under FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls in addition to general controls to ensure their safety and effectiveness. The classification reflects the need for careful oversight of these products, particularly in procedures like transseptal access where precision and reliability are critical.

Yes, Primo Medical Group’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is designed to improve the tracking and identification of medical devices in the U.S., ensuring transparency and traceability throughout the healthcare system. This listing helps healthcare providers and regulators verify the identity and regulatory status of the company’s products.